FDA.reportPublic FDA data

SECQURE Ultimate

Primary DI
00863634000484
Brand
SECQURE Ultimate
Company
SECQURE SURGICAL, CORP.
Model
CQ3850ULT
Device description
Suction / Irrigation Set with Dual Spike
Published
2017-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HETLaparoscope, Gynecologic (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081398000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081398000ADVANCED MEDICAL INNOVATIONS DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIESAdvanced Medical Innovations, Inc.2009-02-06GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863634000484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863634000484008636340004848636340004840863634000484

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration tubing setA collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079554198
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00863634000408SECQURE Ultimate CQ5560ULT2017-09-19
00863634000415SECQURE UltimateCQ5562ULT2017-09-19
00863634000422SECQURE UltimateCQ5465ULT2017-09-19
00863634000439SECQURE Ultimate CQ5460ULT2017-09-19
00863634000446SECQURE Ultimate CQ5462ULT2017-09-19
00863634000453SECQURE UltimateCQ5563ULT2017-09-19
B092CS250CQ'ENCE Circular Stapler 25mmCS25CS252017-10-25
B092CS280CQ'ENCE Circular Stapler 28mmCS28CS282017-10-25
B092CS310CQ'ENCE Circular Stapler 31mmCS31CS312017-10-25
B092CS340CQ'ENCE Circular Stapler 34mmCS34CS342017-10-25
00863634000491SECQURE UltimateCQ3851ULT2017-09-19
00863634000460SECQURE UltimateCQ3442ULT2017-09-19
00863634000477SECQURE UltimateCQ3443ULT2017-09-19

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Primary DI, Brand, Company table
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